Bioequivalence study of Capecitabine Tab 500mg of Qilu Pharmaceutical Co.Ltd,China in comparison with XELODA�® (Capecitabine) Tablets 500 mg, Distributed by Genentech USA, Inc.following a single oral dose administration in adult cancer patients
- Conditions
- Health Condition 1: null- adult cancerHealth Condition 2: D499- Neoplasm of unspecified behavior of unspecified site
- Registration Number
- CTRI/2018/06/014581
- Lead Sponsor
- Qilu Pharmaceutical Co Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 51
1.Male or non-pregnant, non-lactating female patient of age between 18 to 60 years (both inclusive).
2.Patients with histopathologically /cytologically confirmed Dukesââ?¬• C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred.
Or
Patients with histopathologically /cytologically confirmed colorectal carcinoma with evidence of metastasis when treatment with fluoropyrimidine therapy alone is preferred
Or
Patients with histopathologically /cytologically confirmed breast cancer with evidence of metastasis
3.Resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated (e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents). Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracyclineÃ?Âcontaining adjuvant regimen.
4.Cancer patients already receiving a stable twice-daily dosing regimen of capecitabine (who have completed at least one cycle of chemotherapy) as prescribed by the reference product label (i.e. 1250 mg/m2, twice daily, equivalent to 2500 mg/m2 total daily dose, for two-weeks followed by a one-week rest period given as three-week cycles)
5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
6.Adequate cardiac function [left ventricular ejection fraction (LVEF) > 50 %]
7.Patient with adequate bone marrow, renal and hepatic function as defined below:
Body systemParameters
Bone marrow functionANC greater than or equal to 1500/mm3,
Platelet count greater than or equal 100,000/mm3
Hemoglobin greater than or equal to 9.5 g/dL
Renal functionSerum Creatinine less than or equal 1.5 times ULN andcreatinine clearance greater than or equal to 51 to 80 mL/min [Cockroft and Gault]
Hepatic functionBilirubin less than or equal to 1.5 times ULN,
ALT/AST less than or equal to 3 times ULN less than or equal to 5 x ULN if liver metastases present)
8.Patient willing and able to give written informed consent for participation in the study and comply with the study protocol.
9.No persistent clinically significant toxicities from prior medications at screening.
10.Subject with clinically acceptable chest X-Ray (P/A view) whose X-Ray was taken not more than 3 months prior to screening.
11.Females of child-bearing potential (FOCP) must agree to use an acceptable method of birth control such as sexual abstinence or at least 2 reliable modes of contraception, one of which must be a double-barrier method (e.g., condom with spermicidal gel or diaphragm with spermicidal gel) or IUD or vaginal spermicidal suppository from screening until 6 months after last dose of study drug. [Note: Use of hormonal contraception (pills/hormonal intrauterine device etc,) is not allowed].
OR
Post-menopausal females defined as at least 12 consecutive months with no menses without an alternative medical cause
OR
Surgically sterilized females with documented evidence of hysterectomy / bilateral salpingectomy / bilateral oophorectomy. Females without documented evidence o
1. Anti cancer therapy, such as chemotherapy immunomodulatory drug therapy immunosuppressive
therapy including corticosteroids (unless administered to prevent contrast material reactions during radiographic procedures) received within the past 28 days or 5 halflives, whichever is shorter. Low dose chronic use of corticosteroids less than or equal to 10 mg prednisone per day or equivalent is allowed
2.Presence of an acute or chronic toxicity resulting from prior chemotherapy, with the exception of alopecia, that has not resolved to Grade less than or equal 1, as determined by NCI CTCAE v 4.03
3. Radiotherapy within the last 21 days (limited field palliative radiation is allowed if more than or equal to 14 days prior)
4 Known MSI Low or MSS (Microsatellite Stable) status by IHC or known sufficiency of mismatch repair (MMR) genes by PCR
5. Use of any investigational agent within 28 days or 5 half lives (whichever is shorter) prior to Baseline
6. Known symptomatic or untreated or recently treated less than or equal to 6 months of screening central nervous system CNS metastases or CNS lymphoma Patients with previously treated more than 6 months of screening CNS metastases or CNS lymphoma and are now stable and asymptomatic are allowed
7. Progression (clinical or radio graphical) within 9 weeks (63) days of the initiation of most recent therapy
8. Major surgery less than 28 days from the start of treatment (major surgery is defined as a procedure requiring general anesthesia)
9. Minor surgery less than 14 days from the start of treatment (insertion of a vascular access device is not considered either major or minor surgery)
10. Patients who have received an immune checkpoint inhibitor, such as a PD 1 inhibitor (e.g. nivolumab or pembrolizumab), a PD L1 inhibitor (e.g.atezolizumab or avelumab), or a CTLA 4 inhibitor (ipilimumab or tremelimumab) or any other investigational or commercially available immune checkpoint inhibitor in
the11. Active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications (more than to 10 mg per day of prednisone or equivalent). Patients with thyroid dysfunction, on thyroid replacement therapy are allowed. past
12. Active infection requiring systemic therapy. Prophylactic use of antibiotics is allowed
13. Current radiographic evidence or strong suspicion of tuberculosis or history of GI tuberculosis
14. Receipt of any vaccines against infectious diseases (e.g.influenza) within 28 days of study drug administration
15. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome related illness
16. History of allogeneic transplant
17. Relapse within 6 months of an autologous transplant
18. Known active or chronic hepatitis B or hepatitis C infection with known evidence of any of the following:
a. HBsAg positive
b. Hepatitis B DNA positive (Patients with known HBsAg negative but positive Hepatitis B Antibody (either surface or core) must have Hepatitis B DNA negative disease. Hepatitis B DNA test, if not already done, will be ordered as part of screening in such patients)
c. Hepatitis C antibody (anti-HCV)positive, unless patient has been treated and now has undetectable viral load.
19. Uncontrolled congestive heart failure (New York Heart Association NYHA Cla
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate bio equivalence of Capecitabine Tablets 500 mg of Qilu Pharmaceutical Co., Ltd, China in comparison with XELODA�® (Capecitabine) Tablets 500 mg, Distributed by Genentech USA.Timepoint: For outcome, A total of 63 blood samples will be collected during the study. After dosing in each period Day 1, Day 2 and Day 3, the post-dose blood samples of 03 mL each will be drawn at (0.17) 10 min,( 0.33) 20 min, 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours following drug administration
- Secondary Outcome Measures
Name Time Method To monitor the safety and tolerability profile of the study formulation.Timepoint: NA